top management presentation financial results of fy2015(pdf
TRANSCRIPT
Top Management Presentation Financial Results of FY2015
DAIICHI SANKYO CO., LTD Joji Nakayama President and CEO
May 12, 2016
Forward-Looking Statements
1
Management strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi
Sankyo discloses in this material are all classified as Daiichi Sankyo’s future prospects. These forward looking statements
were determined by Daiichi Sankyo based on information obtained as of today with certain assumptions, premises and future
forecasts, and thus, there are various inherent risks as well as uncertainties involved. As such, please note that actual results
of Daiichi Sankyo may diverge materially from Daiichi Sankyo’s outlook or the content of this material. Furthermore, there is
no assurance that any forward-looking statements in this material will be realized. Regardless of the actual results or facts,
Daiichi Sankyo is not obliged and does not have in its policy the duty to update the content of this material from the date of this
material onward.
Daiichi Sankyo takes reasonable care to ensure the accuracy of the content of this material, but shall not be obliged to
guarantee the absolute accuracy, appropriateness, completeness and feasibility, etc. of the information described in this
material. Furthermore, any information regarding companies, organizations or any other matters outside the Daiichi Sankyo
Group that is described within this material has been compiled or cited using publicly available information or other information,
and Daiichi Sankyo has not performed in-house inspection of the accuracy, appropriateness, completeness and feasibility, etc.
of such information, and does not guarantee the accuracy thereof.
The information described in this material may be changed hereafter without notice. Accordingly, this material or the
information described herein should be used at your own judgment, together with any other information you may otherwise
obtain.
This material does not constitute a solicitation of application to acquire or an offer to sell any security in the United States,
Japan or elsewhere.
This material disclosed here is for reference purposes only. Final investment decisions should be made at your own discretion.
Daiichi Sankyo assumes no responsibility for any damages resulting from the use of this material or its content, including
without limitation damages related to the use of erroneous information.
Agenda
2
FY2015 Consolidated Results
FY2016 Consolidated Forecast, Shareholder Returns
Major Management Topics Edoxaban Daiichi Sankyo, Inc. (DSI) R&D Topics
3
FY2015 Consolidated Results
4
FY2014 Results* FY2015 Results YoY
Revenue 919.4 986.4 +67.1
Cost of Sales 323.1 318.6 -4.5
SG&A Expenses 331.2 328.8 -2.4
R&D Expenses 190.7 208.7 +18.0
Operating Profit 74.4 130.4 +56.0
Profit before Tax 79.9 122.4 +42.5
Profit attributable to owners of the Company 46.5 82.3 +35.8
Currency Rate
USD/JPY 109.94 120.14 +10.20 EUR/JPY 138.78 132.57 -6.21
+7.3%
+75.2%
+77.1%
Overview of FY2015 Results
(JPY Bn)
*FY2014 Results have been restated and indicated as only the values for continuing operations.
5
*7.7bn negative impact due to the change of exchange rate of Venezuela etc. is included in “Forex Impact.”
**Forex impact USD:+24.1, EUR:-3.5, ASCA (incl. Venezuela):-7.7
986.4
12.9**
15.5*
2.1
25.9
3.6
18.4
919.4
FY2015 Results
Forex Impact
Asia, South and Central America (ASCA)
Daiichi Sankyo Europe
Luitpold (US)
Daiichi Sankyo, Inc. (US)
Japan (incl. Vaccines, OTC)
FY2014 Results
Japan Positive : Nexium +13.1 Lixiana +9.4 Teneria +9.0 Memary +5.6 Pralia +5.1 Efient +4.2 Ranmark +2.2 Negative : Cravit -9.5 Artist -3.0 Mevalotin -2.7 Inavir -2.6 Global (excl. Forex Impact) Daiichi Sankyo, Inc. : Olmesartan -4.4 Welchol -3.1 Effient +1.4 Movantik +1.8 Luitpold : Injectafer +9.4 Daiichi Sankyo Europe : Olmesartan -3.5 Lixiana +1.6
Revenue
Increased by 67.1 JPY Bn due to the growth of Luitpold, Japan and ASCA with Forex
(JPY Bn)
Positive Factors Negative Factors
6
Cost of Sales increase of revenue
R&D Expenses progress of projects
*Excl. forex impact of special items
130.4
114.8
74.4
74.4
35.7
11.2
11.4
2.5
26.7
67.1
FY2015 Results
Special Items
Forex Impact
R&D Expenses
SG&A Expenses
Cost of Sales
Revenue
FY2014 Results
Operating Profit
Revenue +67.1 incl. forex impact 12.9
Forex impact +11.2* Cost of Sales +3.0 SG&A Expenses +2.8 R&D Expenses +5.4
Special items -35.7 Cost of Sales -34.2 SG&A Expenses -2.7 R&D Expenses +1.2
Increased by 56.0 JPY Bn due to increased revenue and decreased expenses of special items
(JPY Bn)
Positive Factors Negative Factors
7
FY2014 Results FY2015 Results YoY
Cost of Sales
Restructuring costs in Japan 2.2 Impairment loss (Intangible) 35.0
Gain on sales of subsidiary -2.4 Gain on sales of fixed assets -1.1 Impairment loss (Intangible) 1.9 Restructuring costs in supply chain 4.6
-34.2
SG&A Expenses
Settlement expenses with US Department of Justice 4.7 Restructuring costs in Japan 7.3 Restructuring costs in US 1.7 Impairment loss (Tangible) 1.8 Gain on sales of fixed assets -2.9
Restructuring costs in US 15.2 Restructuring costs in EU 2.9 Gain on sales of fixed assets -8.2
-2.7
R&D Expenses Restructuring costs in Japan 4.4 Restructuring costs in R&D 5.6 1.2
Total 54.2 18.5 -35.7
Special Items
- : Cost decrease items
(JPY Bn)
8
Financial Income / Expenses +14.2 FY2014: Forex gain FY2015: Forex loss Expenses relating to the sales of Sun Pharma shares etc.
Income Taxes +5.6 Tax rate FY2014：45.5% FY2015：34.3％
Reduction of reversal of deferred tax asset due to change in tax rate etc. Acceptance of write-off in tax treatment due to capital dividend from a subsidiary which was closed etc.
*Excl. non-controlling interests
82.3*
46.5
5.6
0.6
14.2
56.0
FY2015 Results
Income Taxes etc.
Share of lossof investments
Financial Income/ Expenses
Operating Profit
FY2014 Results
Profit Attributable to Owners of the Company
(JPY Bn)
Increased by 35.8 JPY Bn due to increased operating profit Forex loss due to strong Yen are booked as financial expenses
Positive Factors Negative Factors
9
FY2014 Results
FY2015 Results YoY vs. Forecast
(%)
Japan 480.5 494.7 +14.2 100.7% Daiichi Sankyo Healthcare 47.8 53.4 +5.5 108.9% Daiichi Sankyo Inc. 173.0 185.1 +12.1 105.2% Olmesartan 106.6 111.6 +5.1 110.5%
Welchol 47.4 48.4 +1.0 102.9%
Effient 17.6 20.7 +3.2 -
Savaysa 0.7 0.4 -0.2 22.5%
Movantik - 2.0 +2.0 -
Luitpold 57.4 91.0 +33.6 105.8% Venofer 28.6 31.2 +2.6 104.1%
Injectafer 7.6 18.6 +11.0 109.6%
Daiichi Sankyo Europe 83.5 77.8 -5.7 102.3% Olmesartan 65.2 58.9 -6.3 101.6%
Efient 4.8 5.4 +0.6 -
Lixiana - 1.5 +1.5 90.9%
Asia, South and Central America (ASCA) 67.5 75.3 +7.8 85.6%
Major Business Units (JPY Bn)
10
FY2014 Results
FY2015 Results YoY vs. Forecast
(%)
Olmetec antihypertensive agent 76.3 73.9 -2.5 93.5%
Nexium ulcer treatment 69.3 82.4 +13.1 107.0%
Memary Alzheimer’s disease treatment 36.8 42.4 +5.6 90.3%
Loxonin anti-inflammatory analgesic 49.5 48.1 -1.4 109.4%
Cravit synthetic antibacterial agent 27.8 18.4 -9.5 108.1%
Rezaltas antihypertensive agent 18.4 18.2 -0.2 95.6%
Artist treatment for hypertension, angina pectoris and chronic heart failure 18.1 15.1 -3.0 88.6%
Omnipaque contrast medium 17.2 16.9 -0.3 105.4%
Mevalotin antihyperlipidemic agent 16.2 13.4 -2.7 96.0%
Ranmark treatment for bone complications caused by bone metastases from tumors 10.2 12.4 +2.2 95.3%
Inavir anti-influenza treatment 16.6 14.0 -2.6 116.9%
Urief treatment for dysuria 11.5 11.8 +0.3 107.6%
Pralia treatment for osteoporosis 7.3 12.5 +5.1 124.5%
Lixiana anticoagulant agent 3.6 13.0 +9.4 118.0%
Efient antiplatelet agent 0.7 4.9 +4.2 98.0%
Teneria type 2 diabetes mellitus inhibitor 7.6 16.5 +9.0 -
Major Products in Japan (JPY Bn)
11
FY2016 Consolidated Forecast, Shareholder Returns
12
FY2015 Results
FY2016 Forecast YoY
Revenue 986.4 920.0 -66.4
Cost of Sales 318.6 320.0 +1.4
SG&A Expenses 328.8 310.0 -18.8
R&D Expenses 208.7 190.0 -18.7
Operating Profit 130.4 100.0 -30.4
Profit before Tax 122.4 100.0 -22.4 Profit attributable to owners of the Company
82.3 65.0 -17.3
Currency Rate
USD/JPY 120.14 110.00 EUR/JPY 132.57 125.00
See next page
*Expenses of special items: 18.5 Bn Yen in FY2015
-6.7%
-23.3%
-21.0%
See slide 7
FY2016 Consolidated Forecast
(JPY Bn)
Major factors
Incl. approx. 20.0 Bn* Yen relating to restructuring costs
etc.
FY2015 Results
FY2016 Forecast YoY
Japan 494.7 496.0 +1.3 Daiichi Sankyo Healthcare 53.4 60.0 +6.6 Daiichi Sankyo Inc. 185.1 123.0 -62.1 Olmesartan 111.6 58.0 -53.6 Welchol 48.4 37.0 -11.4 Effient 20.7 - - Savaysa 0.4 2.0 +1.6 Movantik 2.0 - - Luitpold 91.0 92.0 +1.0 Venofer 31.2 25.0 -6.2 Injectafer 18.6 27.0 +8.4 Daiichi Sankyo Europe 77.8 74.0 -3.8 Olmesartan 58.9 46.0 -12.9 Efient 5.4 - - Lixiana 1.5 9.0 +7.5 Asia, South and Central America (ASCA) 75.3 71.0 -4.3 13
(JPY Bn)
Major Business Units FY2016 Forecast
FY2015 Results
FY2016 Forecast YoY
Daiichi Sankyo Inc. (USD Mn) 1,540 1,118 -422 Olmesartan 929 527 -402 Welchol 403 336 -66 Effient 173 - - Savaysa 4 18 +14 Movantik 17 - - Luitpold (USD Mn) 758 836 +79 Venofer 260 227 -33 Injectafer 155 245 +90 Daiichi Sankyo Europe (EUR Mn) 587 592 +5 Olmesartan 444 368 -76 Efient 41 - - Lixiana 12 72 +60
14
(Local Currency)
Major Business Units FY2016 Forecast
15
FY2015 Results
FY2016 Forecast YoY
Nexium ulcer treatment 82.4 80.0 -2.4 Olmetec antihypertensive agent 73.9 68.0 -5.9 Memary Alzheimer’s disease treatment 42.4 51.0 +8.6 Loxonin anti-inflammatory analgesic 48.1 37.0 -11.1 Teneria type 2 diabetes mellitus inhibitor 16.5 28.0 +11.5 Lixiana anticoagulant agent 13.0 25.0 +12.0 Rezaltas antihypertensive agent 18.2 19.0 +0.8 Pralia treatment for osteoporosis 12.5 16.0 +3.5 Ranmark treatment for bone complications caused by
bone metastases from tumors 12.4 13.0 +0.6 Cravit synthetic antibacterial agent 18.4 13.0 -5.4 Inavir anti-influenza treatment 14.0 13.0 -1.0 Omnipaque contrast medium 16.9 12.0 -4.9 Artist treatment for hypertension, angina
pectoris and chronic heart failure 15.1 11.0 -4.1 Urief treatment for dysuria 11.8 11.0 -0.8 Mevalotin antihyperlipidemic agent 13.4 10.0 -3.4 Efient antiplatelet agent 4.9 8.0 +3.1
Major Products in Japan FY2016 Forecast (JPY Bn)
Shareholder Returns
16
Second quarter Fiscal year-end Total
FY2016 (Plan)
ordinary dividend 35 35 70
FY2015 (Results)
ordinary dividend 30 30 60
commemorative dividend 10 - 10
Annual ordinary dividend will be increased from 60 yen/share to 70 yen/share.
Shareholder returns policy during 5YBP Total return ratio : 100% or more Annual ordinary dividends : more than 70 JPY Flexible acquisition of own shares
(Yen)
17
Major Management Topics Edoxaban Daiichi Sankyo, Inc. (DSI) R&D Topics
Edoxaban： FY2016 Global Sales Forecast
18 FY2015 FY2016
15.0
36.3
JPN 13.0
+21.3
US, others
Realize rapid market penetration in Japan and Europe by highlighting unique product profile
EU 1.5
JPN 25.0
EU 9.0
US, others
(JPY Bn)
Japan The only Japan origin DOAC*
with 3 indications Sales capabilities with high quality/credibility
Europe Steady launch in major countries Further promote access models in line with
market needs in each country
*DOAC : Direct Oral Anticoagulant Same meaning as NOAC (novel oral anticoagulant)
Edoxaban：Marketing Structure in Europe
19
DSE promotes Lixiana in 18 countries and books sales. Germany, UK, Ireland, France, Spain, Portugal, Italy, Netherlands, Belgium, Luxembourg, Austria, Switzerland, Turkey etc.
MSD promotes Lixiana in 13 countries and
books sales. Denmark, Finland, Norway, Sweden, Iceland, Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia
DSE MSD
Maximize sales by partnering in countries with no DS sales subsidiary
*MSD: Merck Sharp and Dohme Europe Subsidiary of Merck & Co., Inc.
20
Major Management Topics Edoxaban Daiichi Sankyo, Inc. (DSI) R&D Topics
FY14 FY15 FY16 FY17 FY18 FY19 FY20New Product Launches
Mirogabalin Quizartinib Tivantinib
Pexidartinib Patritumab
FY18
CL-108
CL-108
Mirogabalin
Tivantinib
Quizartinib
Pexidartinib
Pain
Oncology
DSI: Shift in product portfolio With the LOE of key products DSI will transition from a mature
primary care company to one with a differentiated specialty portfolio centered on Pain and Oncology
New products Current products
Patritumab
21
DSI Commercial: Focus Shifts from PCP to New Specialty Product Portfolio
Before Restructuring 2015/10
After Restructuring 2016/4
Sales Force Areas—US Commercial
• Management • Specialty/Hospital • Primary care
• Management • Specialty/Hospital
Sales Force Positions—US Commercial 1,500* 750*
DSI US Commercial Home Office Positions Also Reduced To Reflect Emerging Product Portfolio
DSI US Headquarters Office Co-Location Unite Commercial and Development Divisions
Expected Annual Savings: Total >$250** mn
*Numbers are approximate **Savings estimates are approximate (Restructuring costs in US: 15.2 Bn Yen in FY2015) 22
23
Major Management Topics Edoxaban Daiichi Sankyo, Inc. (DSI) R&D Topics
R&D Topics
Progress of late-phase development pipeline Progress of oncology pipeline Four major late-phase development pipeline Four major early-phase development pipeline DS-6051
New phase 1 product PLX73086/AC708 PLX51107
Innovative technology: diving into cell therapy Research for new stem cells (CapSCs) In-licensed cell therapeutics: Heartcel 24
Progress in late-phase pipeline to NDA CL-108: Novel, opioid-containing formulation to treat moderate to severe
pain while preventing or reducing opioid-induced nausea and vomiting (OINV) Charleston Laboratories, Inc. submitted NDA to U.S. Food and Drug Administration on
March 2016 Targeted for launch in FY2017 Full results from pivotal phase 3 study of patients with moderate to severe pain
following bunionectomy will be presented at the American Pain Society Scientific Meeting in May 2016
Denosumab (anti-RANKL antibody): Treatment of rheumatoid arthritis In DESIRABLE study conducted in Japan, which is a randomized, double-blind,
placebo-controlled Phase 3 clinical trial in patients with rheumatoid arthritis treating with disease-modifying anti-rheumatic drugs (DMARDs), a major objective of the study was achieved in March 2016.
An application for partial changes in approved items in preparation, targeted for launch in FY2017
Hydromorphone*: Narcotic analgesic Oral administration formulation:
Applied for manufacturing/marketing authorization in Japan on March 2016 Injectable formulation: Phase 3 study on-going
25 *: Hydromorphone was publicly offered for development by the Review Committee on Unapproved Drugs and Indications with High Medical Needs organized by MHLW. Daiichi Sankyo decided to develop this drug to give patients an treatment option which is a standard of care for pain associated with cancer.
Four major late-phase development pipeline
26
• Orphan Drug Designation by the FDA and EMA • Fast Track Status by the FDA • Anticipating effectiveness to patients with FLT3-ITD patients
to whom midostaurin doesn’t show efficacy
• Is being launched. Estimated Primary Completion Date: Q4 FY2019
Quizartinib
Tivantinib
Pexidartinib
Patritumab
• Orphan Drug Designation by the FDA and EMA • Refractory HCC • Anticipating high effectiveness by stratification of patients • the independent data monitoring committee (DMC) of the METIV-
HCC study conducted the planned interim assessment and it was determined the trial will continue to its final analysis (Mar 2016)
• Orphan Drug Designation by the FDA and EMA • Breakthrough Therapy designation by FDA • On track • Combination therapy with Merck’s anti-PD-1 antibody • On track
Acute myeloid leukemia (AML) 2nd line (P3)
TLR: 1H CY2017
Hepatocellular carcinoma (HCC)(P3)
TLR: 1H CY2017
Non-small cell lung cancer (P2/3)
TLR: 2H CY2018 Head and Neck
cancer（P2)
Tenosynovial giant cell tumor
(TGCT)(P3) TLR: 1H CY2018
Solid tumor(P1/2a) TLR: 2H CY2019
Update during Q4 FY2015 written in red TLR：anticipated Top Line Result
• Anticipating high effectiveness in specific group of patients selected by biomarker
• Promising data for a single-arm phase 1 study in combination with cetuximab and a platinum containing therapy for patients with recurrent and metastatic head and neck cancer
• Data to be published at ASCO in June 2016
1st line (P3)
Four major early-phase development pipeline
27
DS-8201 (HER2-ADC)
DS-3201 (EZH1/2)
DS-3032 (MDM2)
DS-6051 (NTRK/ROS1)
Solid tumor (P1)
Non-Hodgkin's lymphoma
（incl. adult T-cell leukemia）(P1)
Solid Tumor （Lung cancer）
Solid tumor Hematologic tumor(P1)
• Anticipating effectiveness to patients resistant to treatment by Herceptin or Kadcyla
• Applied DS proprietary ADC* technology • Target: obtaining of phase 1 results in FY2017 • On track
*:Antibody Drug Conjugate
• Targeted epigenetics** • Aiming at permanent cure of hematological cancer by eradication of
“cancer stem cell” • FIC as an EZH１/2 dual inhibitor • Anticipating More potent as compared to EZH2 inhibitor • Started phase1 clinical study (Mar 2016) • Target: completion of phase 1 study in FY2018
**:chemical modification of DNA or histone leading to acquired change in gene expression without modification of DNA sequence
• ROS1 fusion is one of the major driver mutations observed in lung cancer etc.
• Phase 1 study is planned to complete in FY2017 (US/JP) • Partial response is observed in a patient in US phase1 study.
Interim analysis of efficacy and safety was presented at AACR in April 2016.
• Utilizing SCRUM-Japan*** for patient selection in Japan
• Anticipating high effectiveness to cancer with MDM2 gene amplification/Wt p53
• FIC • Based on the phase 1 study in the US suggesting effectiveness in
patients with liposarcoma (LPS), LPS is selected as a potential indication for further development, which is under consideration
• On track
***SCRUM-Japan: National project led by National Cancer Center Japan to screen oncogenic abnormality of cancer patients in order to provide the best-fit medicines to them
Update during Q4 FY2015 written in red
DS-6051: NTRK/ROS1 inhibitor
Partial response in a patient who had prior crizotinib and ceritinib therapies with metastatic NSCLC ROS1+ w/ liver metastases was confirmed in Phase 1 study in US* First report for Ros1 inhibitor which is effective to a tumor patient who is
resistant to crizotinib Currently on treatment in Cycle 13 (from July 2015)
Started phase 1 study in Japan (Q4 FY2015) Initiated in February 2016 in collaboration with SCRUM-Japan** Oral once-daily (QD) continuous dosing, 21-day cycle
28
*Presented at American Association for Cancer Research (AACR) annual meeting Apr 16-20 2016 ** Cancer Genome Screening Project for Individualized Medicine in Japan
DS-6051: NTRK/ROS1 inhibitor
Diagnostic image of patient with Partial Response Observed anti-tumor effect
29
After 9 weeks on therapy
(September 2015)
Baseline (July 2015)
New Phase 1 product
PLX73086/AC708: CSF-1R inhibitor Fast follow-on to Pexidartinib, potential best-in-class Improved selectivity relative to Pexidartinib Target indication: Tenosynovial Giant Cell Tumor (TGCT) Summary of the phase 1 study Study objectives
• Primary: safety, PK&PD • Secondary: efficacy (ORR)
Part1: Open-label, dose escalation in solid tumors subjects Part2: Extension cohort at the recommended phase 2 dose (RP2D)
in subjects with histologically confirmed, unresectable, locally advanced or refractory TGCT
Estimated Primary Completion: Q4 FY2018
30
New Phase 1 product
PLX51107: BRD4 inhibitor BRD4
A member of BET (Bromodomain and Extra-Terminal domain) protein family Recruit regulatory complexes to influence gene expression, especially
oncogenes, such as c-MYC Epigenetic target potential
PLX51107 inhibits the interaction between BRD4 and acetylated lysines of histones to down-regulate expressions of oncogenes
Summary of the phase 1 study Study objectives
• Primary: safety, PK and MTD/RP2D • Secondary: ORR, DOR, PFS • Exploratory: gene expression (e.g. c-MYC)
in tumor cells and tumor biopsies Estimated study completion: Q4 FY2017
31
Innovative technology: Diving into cell therapy
32
Cell therapy business environment A revolutionary therapeutic technology with full potential still to be defined Autologous vs. Allogeneic
Autologous: Advanced technology with challenges about business potential to be defined Allogeneic: many technical hurdles to be defined
Cell therapy related regulations have been enacted in Japan, but it is unclear how to make such technology into a sustainable business We will have to partner with regulators regarding clinical study, pharmaceutical affairs,
manufacturing etc.
Our strategy Capitalize licensing and partnering with many companies and academies to
mitigate enterprise risk and accelerate business development Create synergy by bringing each company/academia’s strength Catch up with top group together and establish a business foundation and business
model
Innovative therapy which changing SOC for patients
Innovative technology: New technology for cell therapeutics
In-licensed HeartcelTM technology from Cell Therapy Ltd, CTL, based in the UK
33
CTL technology CTL has developed a novel and proprietary platform, based on the stem cell
discoveries of Professor Sir Martin Evans, Nobel prize winner, which can discover tissue- and disease-specific progenitor cells from healthy donor blood CTL is developing a range of allogeneic therapies for different indications by
selecting a cell appropriate for target disease Heartcel is designed to avoid rejection, and has immuno-modulatory and
regenerative properties
Heart-specific immuno-modulatory cells ⇒ Heartcel
Innovative technology: New technology for cell therapeutics
A part of the licensing conditions Expected as a treatment for sever ischemic heart failure Development stage： in preparation for Phase 3 study in EU, in preparation for Phase 1 study in Japan Territory： Japan Role: Daiichi Sankyo: Development & sales
CTL: Manufacturing of investigational drug and commercial drug
34
Modified from ‘Understanding What Went Wrong’ by Laura E. Smith
Heartcel: Route of administration
Intra-myocardial injection with CABG*
Regeneration of ischemic scar tissue is
expected by administration to the infarcted
site of the heart
* Coronary Artery Bypass Graft
Innovative technology: Research for new stem cell
35
Started an collaborative research to develop new cell therapy on new stem cells with Asahikawa Medical University in April 2016 Therapeutic use of capillary stem cell (CapSCs) for various kinds of
diseases in addition to a practical use of the CapSCs stem cells as a source of therapy will be investigated.
What are CapSCs: New somatic stem cells isolated and identified by the joint research of Prof.
Kawabe in Asahikawa Medical University and Asubio Pharma Co., Ltd, a member of Daiichi Sankyo group
Have potential to be differentiated into various kinds of tissues, such as blood vessel, nerve and skeletal muscle
Has potential as a regenerative medicine treatment for wide range of diseases like lower leg ischemia, ischemic heart disease, sarcopenia, nerve-related disease and so on.
Innovative technology: Research for new stem cell
36
CapSCs group Control group
Example of therapeutic effect of CapSCs transplantation experiment with model mice of sever lower leg ischemia. CapSC treatment dramatically inhibited necrosis of lower leg caused by ischemia
Open innovation research scheme utilizing OiDE Fund
37
Asahikawa Medical
University
Daiichi Sankyo (Asubio Pharma)
OiDE CapiSEA, Inc
OiDE Fund
Start of Joint research
Research institution
Research support
100%-owned
In case of meeting success factors DS will acquire all stocks from OiDE CapiSEA and the research program will shift to the R&D project of DS
Equity investors Daiichi Sankyo, Mitsubishi UFJ Capital, Organization for Small & Medium Enterprises and Regional Innovation, others Daiichi Sankyo and Mitsubishi UFJ
Capital will seek out promising research results (“seeds”) at Japanese universities that could potentially result in platform technologies.
Joint research expenses
Major R&D milestone events
38
Project Indication/Study Event Target CHS-0214 （etanercept BS）
Rheumatoid arthritis (JP) NDA FY2016
Denosumab Rheumatoid arthritis (JP) NDA FY2016
Prasugrel Ischemic cerebrovascular disease Phase 3 study (JP) TLR* H1 FY2016
DS-8500 Type 2 Diabetes phase 2b study (JP) TLR Q4 FY2016
TLR*: Top Line Result
project Study
DS-8500 Type 2 Diabetes phase 2a study (JP) Elected as the topic for the late breaking session of the American Diabetes Association (ADA) 76th scientific sessions June 10-16, 2016
<Publication of results of major clinical studies in academic conference>
<Milestones towards NDA submission>
Phase 1 Phase 2 Phase 3 Application Therapeutic area
Cardiovascular- Metabolics
Oncology
Others
Prasugrel (JP) (CS-747 / Ischemic stroke / Anti- platelet agent)
Edoxaban (ASCA etc.) (DU-176b / AF / oral factor Xa inhibitor)
Edoxaban (ASCA etc.) (DU-176b / VTE / oral factor Xa inhibitor)
Tivantinib (US/EU) (ARQ 197 / HCC / MET inhibitor)
Denosumab (JP) (AMG 162 / Breast cancer adjuvant / Anti-RANKL antibody)
Nimotuzumab (JP) (DE-766 / Gastric cancer / Anti-EGFR antibody)
Vemurafenib (US/EU) (PLX4032 / Melanoma Adjuvant / BRAF inhibitor)
Quizartinib (US/EU/Asia) (AC220 / AML-2nd / FLT3-ITD inhibitor)
Quizartinib (US) (AC220 / AML-1st / FLT3-ITD inhibitor)
Pexidartinib (US/EU) (PLX3397 / TGCT / CSF-1R/KIT/FLT3-ITD inhibitor)
Laninamivir (US/EU) (CS-8958 / Anti-influenza / out-licensing with Biota)
Mirogabalin (US/EU) (DS-5565 / Fibromyalgia / α2δ ligand)
Mirogabalin (JP/Asia) (DS-5565 / DPNP/ α2δ ligand)
Mirogabalin (JP/Asia) (DS-5565 / PHN / α2δ ligand)
Denosumab (JP) (AMG 162 / Rheumatoid arthritis / Anti-RANKL antibody)
Hydromorphone (JP) (DS-7113 / Cancer pain / Opioid μ-receptor regulator) <Injection>
CHS-0214 (JP) (Etanercept BS / Rheumatoid arthritis / TNFα inhibitor)
VN-0105 (JP) (DPT-IPV / Hib vaccine)
VN-0107/MEDI3250 (JP) (Nasal spray flu vaccine vaccine)
CS-3150 (JP) (Hypertension ・ DM nephropathy / MR antagonist)
DS-8500 (JP/US) (Diabetes / GPR119 agonist)
Patritumab (US/EU) (U3-1287 / Anti-HER3 antibody)
Pexidartinib (US) (PLX3397 / CSF-1R/KIT/FLT3-ITD inhibitor)
DS-1040 (Acute ischemic stroke / TAFIa inhibitor)
DS-2330 (Hyperphosphatemia)
DS-9231/TS23 (Thrombosis / α2-PI inactivating antibody)
DS-9001 (Dyslipidemia / Anti-PCSK9 Anticalin-Albumod)
DS-3032 (US/JP) (MDM2 inhibitor)
PLX7486 (US) (FMS / TRK inhibitor)
PLX8394 (US) (BRAF inhibitor)
DS-6051 (US/JP) (NTRK/ROS1 inhibitor)
PLX9486 (US) (KIT inhibitor)
DS-3201 (JP) (EZH1/2 inhibitor)
PLX73086 (US) (CSF-1R inhibitor)
PLX51107 (US) (BRD4 inhibitor)
DS-1971 (Chronic pain)
DS-1501 (Osteoporosis / Anti-Siglec-15 antibody)
DS-7080 (US) (AMD / Angiogenesis inhibitor)
DS-2969 (Clostridium difficile infection /GyrB inhibitor)
DS-5141 (JP) (DMD / ENA oligonucleotide)
VN-0102/JVC-001 (JP) (MMR vaccine)
Hydromorphone (JP) (DS-7113 / Cancer pain / Opioid μ-receptor agonist)<Oral>
CL-108 (US) (Acute pain / Opioid μ-receptor agonist)
Intradermal Seasonal Influenza Vaccine (JP) (VN-100 / prefilled i.d. vaccine for seasonal flu)
Major R&D Pipeline DS-8895 (JP)
(Anti-EPHA2 antibody)
DS-8273 (US) (Anti-DR5 antibody)
DS-5573 (JP) (Anti-B7-H3 antibody)
DS-8201 (JP) (Anti-HER2 ADC)
U3-1784 (EU) (Anti-FGFR4 antibody)
DS-1123 (JP) (Anti-FGFR2 antibody)
Red: Major changes after the FY2015 Q3 financial announcement on January 29, 2016 39
As of May 2016
Introducing Daiichi Sankyo Cancer Enterprise: Creating a transformation
Executive VP & Global Head R&D Oncology Antoine Yver, MD MSc
Global Head, Oncology R&D, Antoine Yver
Former Pediatrician Oncologist, academic faculty Paris, France
Former Head, Oncology Global Medicines Development at AstraZeneca (2009-2016)
26 years pharma experience in global R&D, including early & late phase development and licensing
Global clinical leader for 12 marketing applications in oncology, 4 new drugs
In addition, in 2015: olaparib (PARPi), osimertinib (3rd-G mut-EGFRi T790M)+
Multinational line management experience for development functions, including Japan R&D and China R&D
+ Yver A, Osimertinib (AZD9291)—a science-driven, collaborative approach to rapid drug design and development Annals Oncology April 2016 (on line) 41
My values
42
Rigorous science, pursuing unique patient needs
Simplicity, decentralized decision-making allowing autonomy and accountability
Do the hard, right thing
Take seriously what we do, don’t take ourselves seriously
Be passionate and competitive externally
Focus and prioritize
Relentless pursuit of perfection
Be courageous, creative, collaborative, candid
DS opportunity in oncology
Needs In 2012, 8.2 million cancer-related deaths worldwide New cancer cases are expected to rise from 14 to 22 million
within the next two decades World population is aging, and cancer rates increase with
age Opportunity Six new US/Japan INDs for oncology agents in FY2015 Market continuously reshaping; medical needs far from
being fully addressed Immuno-oncology is yet to mature: with today’s science, only a
fraction of cancer patients can hope to benefit Many opportunities to be either first- or best-in-class
SCIENCE-DRIVEN, COMPETITIVE, FOCUSED, WITH EXCELLENCE
43
Daiichi Sankyo Cancer Enterprise: Creating a transformation
44
DS Cancer Enterprise:
To lead in science and transform
evidence into value
for cancer patients in need
Enterprise: what do we mean?
45
“A professional firm seeking to achieve ultimate solutions for patients with cancer”
“A dedicated group pursuing entrepreneurial behavior together, driven by each member’s
initiatives, expertise and passion”
Come together and work together beyond boundaries and titles Desire to go beyond limits, i.e., beyond boundaries, limitations, breaking
points All this for a noble cause
My Vision for DS Cancer Enterprise: Be perfect in 3 areas
46
Select with discipline the right molecules & technologies in which to invest
Design efficient, effective & differentiated strategies and products based upon data, facts, observations and patient/customer/expert insights
Deliver on our strategy and thereby delight DS in its transformation
Transformation stemming from 4 pillars
47
Cancer Enterprise
Grow and enrich talent
base and ways of working
Select the most valuable & promising
assets to ensure we
compete at our best, and secure/
accelerate delivery plans
Refresh the 2014-2015
Oncology R&D portfolio strategy
Create the right support for the teams
Contact address regarding this material
Daiichi Sankyo Co., Ltd.
Corporate Communications Department
TEL: +81-3-6225-1126